Medicines Articles
Baxter International has received U.S. Food and Drug Administration approval for a 4,000 IU dosage of Advate (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free Method).
CSL Behring has been granted orphan drug designation by the U.S.Food and Drug Administration for its novel recombinant fusion protein linking coagulation factor VIIa with albumin (rVIIa-FP).
Recent studies suggest that the divergent outcomes in Alzheimer’s disease clinical studies of intravenous immune globulin (IVIG) may be due to differences in temporal administration and administered dosages.
Cangene Corp. has issued a voluntary recall of several finished product lots associated with one bulk lot of Hepatitis B Immune Globulin ([Human] HepaGam B > 312 IU/mL).
The U.S. Food and Drug Administration approved Baxter International Inc.’s Advate (antihemophilic factor [recombinant] plasma/albumin free method) for hemophilia A.
The U.S. Food and Drug Administration and the Committee for Medicinal Products for Human Use in Europe have approved the return of Octagam 5% (human normal immunoglobulin 50 mg/ml) to the market. Marketing authorization was suspended in August 2010 in the U.S.
Panacea Biotec, an India-based biotechnology firm, has introduced a generic breast cancer treatment medicine called PacliALL.
The U.S. Food and Drug Administration has granted marketing approval for Corifact Factor XIII Concentrate (Human) for the routine prophylactic treatment of congenital factor XIII(FXIII) deficiency.
The U.S.Food and Drug Administration has approved a novel type of cancer vaccine called Yervoy.
The Ritedose Corp. is voluntarily recalling its 0.083% Albuterol Sulfate Inhalation Solution, 3 mL in 25-, 30- and60-unit dose vials.
Bristol-Myers Squibb’s ipilimumab has shown early promise for helping patients with advanced melanoma that has spread to the brain.
A first-of-its-kind prostate cancer treatment that uses the body’s immune system to fight the disease has been approved by the U.S. Food and Drug Administration.